PainNCT06183957
The Effect of Shower on Birth Pain, Postpartum Fatigue and Comfort
A study testing hydrotherapy group in people with Pain and Fatigue, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- hydrotherapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Voluntarily agreeing to participate in the study
- She will have her second birth spontaneously vaginally at term (between 37-42 weeks of pregnancy).
- The fetal weight estimated by ultrasound is 2500-4000 grams
- Single fetus and head presentation
- Being in the active phase of labor (cervical dilation 4 cm)
- Ability to establish written/verbal communication
- Not taking any analgesia or anesthesia to relieve pain and fatigue before birth and during labor.
- Newborn APGAR score is 7 or above
Who cannot join
- giving up on research
- Having received infertility treatment
- Birth by cesarean section
- Having an interventional birth (forceps, vacuum, episiotomy application)
- Being primiparous, having a third or more birth (grandmultiparous)
- Having any systemic, chronic and neurological disease (Diabetes Mellitus, Hypertension, Thyroid diseases, Multiple Sclerosis, Epilepsy, etc.)
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- Regular use of medication due to any disease
- Receiving psychiatric treatment (pharmacotherapy/psychotherapy)
- Any induction application that will affect uterine contractions and dilation
- Having any pregnancy complications (placenta previa, preeclampsia, premature rupture of membranes, oligohydramnios and polyhydramnios, contraction anomalies, presentation disorder, intrauterine growth retardation, intrauterine dead fetus, macrosomic babies, fetal distress, etc.)
- Having any problem that prevents communication (such as not knowing Turkish, hearing, speaking and understanding impairment),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Çorlu District State Hospital
Tekirdağ, Tekirdağ
About this study
According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Birth pain is the most severe pain experience known and defined, with physiological as well as psychological and sociocultural components that may vary among individuals.Pharmacological and non-pharmacological applications are used to relieve birth pain. While pharmacological methods reduce pain, they distract women from the physiological reality of birth and prevent women from accepting pain as a natural part of birth. Non-pharmacological methods are alternative options that will help women manage pain during birth by ensuring that women experience pain.
Showering (hydrotherapy), one of the non-pharmacological methods used to reduce pain in labor, is used to increase relaxation and reduce birth pain. In a study conducted domestically, it was stated that the use of hydrotherapy during labor pain helped the woman relax, reduced the pain felt, lowered blood pressure and increased diuresis. Fatigue, in addition to being a universal symptom associated with diseases, is also a common complaint among healthy individuals.
In line with the literature information, this study aims to examine the effect of shower applied during birth on postpartum fatigue and postpartum comfort.
Read the detailed description
According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Birth pain is the most severe pain experience known and defined, with physiological as well as psychological and sociocultural components that may vary among individuals. Physiological components; The pressure on the tissues of the birth canal and the stretching of the tissues are psychosocial components; It is related to fear, anxiety and coping ability during the birth process. The individual's response to pain with cultural values and learned behaviors constitutes the sociocultural dimension of pain. In addition to these known characteristics of labor pain, the degree of pain varies according to the frequency, duration and intensity of contractions and the cervical opening. The American Society of Obstetrics and Gynecology states that labor pain should be treated and that it may have negative effects on maternal and neonatal health in cases where the pregnant woman has difficulty coping with labor pain.
Pharmacological and non-pharmacological applications are used to relieve birth pain. While pharmacological methods reduce pain, they distract women from the physiological reality of birth and prevent women from accepting pain as a natural part of birth. Non-pharmacological methods are alternative options that will help women manage pain during birth by ensuring that women experience pain. The World Health Organization (WHO) recommends the use of non-pharmacological methods such as massage and touching, distraction and imagination, movement and position, music, making sounds and praying, aromatherapy, hydrotherapy, acupressure, hot and cold applications in labor pain.
Showering (hydrotherapy), one of the non-pharmacological methods used to reduce pain in labor, is used to increase relaxation and reduce birth pain. In a study conducted domestically, it was stated that the use of hydrotherapy during labor pain helped the woman relax, reduced the pain felt, lowered blood pressure and increased diuresis. The use of water during labor and regular feeding of the uterus in the first stage of labor has helped to feel less pain during contractions and to have shorter and less invasive births.
Fatigue, in addition to being a universal symptom associated with diseases, is also a common complaint among healthy individuals. The North American Nursing Diagnosis Association (NANDA) defines fatigue as "a predominant, persistent feeling of exhaustion and a decrease in normal physical and mental working capacity". defines. Symptoms of fatigue; Inability to carry out daily tasks, impaired concentration, difficulty in remembering, short-term memory loss, indifference to the environment, decreased awareness, lack of energy, fatigue, difficulty in making decisions, muscle weakness, increased physical complaints, emotional changes, tendency to sleep, hallucinations, perceptual weakness. is suffering.
Fatigue is a common symptom during pregnancy, birth and the postpartum period. In addition to being a very special, happy experience for women, birth also means coping with physical pain and difficulties and fatigue due to insomnia. With the birth, the six-week period begins, called the postpartum period, during which the woman feels social, physical and psychological changes. This process is a woman's; It is a difficult period in which all systems and organs in the body return to their pre-pregnancy state, the woman tries to adapt to the new roles and responsibilities acquired in the transition to parenthood, and many progressive and regressive changes occur in the woman's body. Fatigue, which is an inevitable part of this period, can increase until the sixth postpartum week. In the study of Kılıç et al., it was reported that 88.5% of women experienced fatigue in the postpartum period.
In line with the literature information, this study aims to examine the effect of shower applied during birth on postpartum fatigue and postpartum comfort.
- Being tested
- hydrotherapy group
- Keywords
- Postpartum period, Postpartum comfort, Hydrotherapy
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapy groupOther
When women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm.
| Study group | Role | What they receive |
|---|---|---|
| hydrotherapy group | Experimental | When women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm. Receives: Other: hydrotherapy group |
| Control group | No intervention | Women in this group will not undergo any treatment other than routine hospital protocol (midwifery care). Additionally, the vital signs (blood pressure, pulse) of the participants will be measured and recorded hourly by the midwife. These data will be recorded in each participant's file. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period
Measured: 1 week
Secondary outcomes (3)
Visual Comparison Scale (VAS)
It is stated that the Visual Comparison Scale (VAS) is more sensitive and reliable in measuring pain intensity than other unidimensional scales. VAS is a 10 cm ruler with no pain written on one end and the most severe pain possible on the other end. Evaluation of VAS is defined as No pain: 0 cm, Mild pain: 0.5 cm - 3.0 cm, Moderate pain: 3.5 cm - 6.5 cm, Severe pain: 7.0 cm - 10.0 cm. VAS is a very sensitive method in the evaluation of pharmacological and non-pharmacological treatments that reduce pain and is a scale in the form of vertical or horizontal, visual, numerical or descriptive analogue.
Measured: during labour period (up to 10 hours)
Postpartum Comfort Scale (WSCO)
It is a scale that can be used appropriately and safely in measuring the postpartum comfort of mothers who have given birth by normal birth or cesarean section, in meeting postpartum comfort needs, and in evaluating the outcome as a concrete indicator of the outcome. Its consists of 34 items. A 5-point Likert-type scale scoring system was used to enable an evaluation for each item that determines the situation to be measured. For each item, expressions and scoring ranging from "completely agree" (5 points) to "strongly disagree" (1 point) were made. The lowest score to be obtained from the scale is 34 and the highest score is 170.
Measured: between 2-4 hours postpartum period
Person-Oriented Maternity Care Scale
The original scale has 30 items and 3 subscales. The Turkish form consists of 21 items and 3 sub-dimensions. Except for items 6, 11 and 13 (5 options and coded as 0, 1, 2, 3, 4), the remaining items have 4 options ("no, never" 0, "yes, a few times" 1, "yes, most of the time" "time" is scored as 2, "yes, always" is scored as 3). The lowest score that can be obtained from the total scale is 0, the highest score is 66, the lowest score that can be obtained from the "Value and Respectful Care" sub-dimension (2,3,4,5) is 0, the highest score is 12, "Communication and Autonomy" (1,6,7). The lowest score that can be obtained from the "Supportive Care" sub-dimension (12,13,15,16,17,18,19,20,21) is 0 and the highest score is 26. The lowest score is 0 and the highest score is 28. As the score increases, mother-focused care increases.
Measured: between 2-4 hours postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start3 Mar 2023
- Primary completion15 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- ZEYNEP CAMBAZ, Principal investigator, Tekirdağ Çorlu İlçe Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183957
- Sponsor's protocol ID
- KırklareliAS-9
- Status last verified
- Jun 2024
- First submitted
- 12 Dec 2023
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shower on Birth Pain, Postpartum Fatigue and Comfort
- ClinicalTrials.gov ID
- NCT06183957
- Acronym / sponsor ID
- KırklareliAS-9
- Keywords
- Postpartum period, Postpartum comfort, Hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Birth pain is the most severe pain experience known and defined, with physiological as well as psychological and sociocultural components that may vary among individuals.Pharmacological and non-pharmacological applications are used to relieve birth pain. While pharmacological methods reduce pain, they distract women from the physiological reality of birth and prevent women from accepting pain as a natural part of birth. Non-pharmacological methods are alternative options that will help women manage pain during birth by ensuring that women experience pain.
Showering (hydrotherapy), one of the non-pharmacological methods used to reduce pain in labor, is used to increase relaxation and reduce birth pain. In a study conducted domestically, it was stated that the use of hydrotherapy during labor pain helped the woman relax, reduced the pain felt, lowered blood pressure and increased diuresis. Fatigue, in addition to being a universal symptom associated with diseases, is also a common complaint among healthy individuals.
In line with the literature information, this study aims to examine the effect of shower applied during birth on postpartum fatigue and postpartum comfort.
Detailed description
According to the definition of the International Association for the Study of Pain, pain; It is an unpleasant sensory and emotional sensation and behavior related to the individual's past experiences, caused by real or potential tissue damage originating from any part of the body. Birth pain is the most severe pain experience known and defined, with physiological as well as psychological and sociocultural components that may vary among individuals. Physiological components; The pressure on the tissues of the birth canal and the stretching of the tissues are psychosocial components; It is related to fear, anxiety and coping ability during the birth process. The individual's response to pain with cultural values and learned behaviors constitutes the sociocultural dimension of pain. In addition to these known characteristics of labor pain, the degree of pain varies according to the frequency, duration and intensity of contractions and the cervical opening. The American Society of Obstetrics and Gynecology states that labor pain should be treated and that it may have negative effects on maternal and neonatal health in cases where the pregnant woman has difficulty coping with labor pain.
Pharmacological and non-pharmacological applications are used to relieve birth pain. While pharmacological methods reduce pain, they distract women from the physiological reality of birth and prevent women from accepting pain as a natural part of birth. Non-pharmacological methods are alternative options that will help women manage pain during birth by ensuring that women experience pain. The World Health Organization (WHO) recommends the use of non-pharmacological methods such as massage and touching, distraction and imagination, movement and position, music, making sounds and praying, aromatherapy, hydrotherapy, acupressure, hot and cold applications in labor pain.
Showering (hydrotherapy), one of the non-pharmacological methods used to reduce pain in labor, is used to increase relaxation and reduce birth pain. In a study conducted domestically, it was stated that the use of hydrotherapy during labor pain helped the woman relax, reduced the pain felt, lowered blood pressure and increased diuresis. The use of water during labor and regular feeding of the uterus in the first stage of labor has helped to feel less pain during contractions and to have shorter and less invasive births.
Fatigue, in addition to being a universal symptom associated with diseases, is also a common complaint among healthy individuals. The North American Nursing Diagnosis Association (NANDA) defines fatigue as "a predominant, persistent feeling of exhaustion and a decrease in normal physical and mental working capacity". defines. Symptoms of fatigue; Inability to carry out daily tasks, impaired concentration, difficulty in remembering, short-term memory loss, indifference to the environment, decreased awareness, lack of energy, fatigue, difficulty in making decisions, muscle weakness, increased physical complaints, emotional changes, tendency to sleep, hallucinations, perceptual weakness. is suffering.
Fatigue is a common symptom during pregnancy, birth and the postpartum period. In addition to being a very special, happy experience for women, birth also means coping with physical pain and difficulties and fatigue due to insomnia. With the birth, the six-week period begins, called the postpartum period, during which the woman feels social, physical and psychological changes. This process is a woman's; It is a difficult period in which all systems and organs in the body return to their pre-pregnancy state, the woman tries to adapt to the new roles and responsibilities acquired in the transition to parenthood, and many progressive and regressive changes occur in the woman's body. Fatigue, which is an inevitable part of this period, can increase until the sixth postpartum week. In the study of Kılıç et al., it was reported that 88.5% of women experienced fatigue in the postpartum period.
In line with the literature information, this study aims to examine the effect of shower applied during birth on postpartum fatigue and postpartum comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| hydrotherapy group | Experimental | Other: hydrotherapy groupWhen women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm. |
| Control group | No intervention | –Women in this group will not undergo any treatment other than routine hospital protocol (midwifery care). Additionally, the vital signs (blood pressure, pulse) of the participants will be measured and recorded hourly by the midwife. These data will be recorded in each participant's file. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- -Voluntarily agreeing to participate in the study
- She will have her second birth spontaneously vaginally at term (between 37-42 weeks of pregnancy).
- The fetal weight estimated by ultrasound is 2500-4000 grams
- Single fetus and head presentation
- Being in the active phase of labor (cervical dilation 4 cm)
Key exclusion criteria (11 listed)
- giving up on research
- Having received infertility treatment
- Birth by cesarean section
- Having an interventional birth (forceps, vacuum, episiotomy application)
- Being primiparous, having a third or more birth (grandmultiparous)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapy groupWhen women in this group are taken to their labor rooms (when the dilation is 4-5cm), they should be standing or standing, depending on their preferences, on their waist, abdomen or whole body, with the temperature of the water between 32-37 °C (the temperature preferred by the woman will be applied) for at least 20 minutes. Sitting shower application will be performed under the observation of the researcher midwife. The temperature of the flowing water will be measured with a bucket and a thermometer that helps evaluate the temperature. The application will be repeated when the dilation is 6-8 cm. | Other | hydrotherapy group |
Primary outcome
Introductory Information Form
Time frame: 1 week
sociodemographic characteristics, medical and obstetric pregnancy history, the woman's current pregnancy, prenatal and postpartum period
3 secondary outcomes
Visual Comparison Scale (VAS)
Time frame: during labour period (up to 10 hours)
Postpartum Comfort Scale (WSCO)
Time frame: between 2-4 hours postpartum period
Person-Oriented Maternity Care Scale
Time frame: between 2-4 hours postpartum period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZEYNEP CAMBAZ principal investigator
Tekirdağ Çorlu İlçe Devlet Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy group in people with Pain and Fatigue, run by Kırklareli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2024.